DIACEPH
CNS SHUNT MONITORING SYSTEM: Test Description
This test is intended
for patients who are conscious and four (4) years of age through late senior who
can respond and answer queries, similar to a physician interview and
cooperation required of a standard hearing test. Test reliability becomes standardized to each
patient with on-going use. We have authored a new tandem DiaCeph/single in-office shunt tap
protocol which verifies
the accuracy of DiaCeph data, and broadens the information possible
through a single shunt tap. DiaCeph Testing is intended to further the
diagnostic work-up of shunt malfunction, pre-surgical shunt selection,
calibration of programmable shunts, NPH work-ups, and post discharge monitoring of
both shunted and
ETV'd patients. DiaCeph's AI software and algorithms (SEE PDF file at
right) form the foundation for monitoring,
via overlays of incident data to earlier baseline data, and
corroboration with clinical symptoms and in-office ICP taps. DiaCeph monitoring
is higher in sensitivity and specificity than CT, MRI, isotope clearance, or ICP
taps alone.
The PDA device is designed for downloading data to a
DiaCeph PC program, where it can be emailed or posted to a web site, or uploaded
through a telephone system. Test results
include comparative graphs of shunt patency, relative ICP, individual
parameters, and post interventional testing. Testing is best done at set times during
the day, typically 4 to 8 samples per day. Incident samplings and episodic
samplings employing predetermined "interventions" may be used to evaluate
complex shunt malfunction in real time. Data is plotted on Time v. Value graphs to provide visual displays of
shunt performance. A database of findings of various shunt systems could be quite useful.
The effect of its overall capabilities enables it to function as both a
diagnostic device, and an advanced disease management program by archiving
detailed shunt performance and patient status information over a long period of
time.
Description of the DiaCeph
Test
The DiaCeph Test's principal components are a stand alone
DiaCeph
Test Features and Benefits
• Portable, User Friendly Menu Prompts • Standard and Advanced Testing
• Results Available at Touch of a Button • Single or Pre-set Serial Sampling
• Up to Date Cognitive Assessment Tests • Results Sent to PC and/or Internet
• Contraindications Warning Alert • Prints Time vs. Parameter Graphs
• Accommodates a Variety of Patient • Maintains Patient Profiles
• Provides Estimate of Relative ICP • Increases Access to Medical Care
• High Level of Sensitivity to Malfunction • Reduces Needless Doctor/ER Visits
• Helps Manage Daily Schedules • Assessment of Shunt Patency
NEW: Tandem Application with a Single In-Office ICP Shunt Tap
Sample Collection:
To collect a sample, the user would select either the Standard, Advanced, Pre-Set Timed, or Interventional protocol. The auto-program then prompts the user to select the patient's Activity that preceded the sample by selecting it from a list of activities that appear on the screen. Next, it prompts the user with instructions to determine the patient's level of Nausea, and select it on the display screen using a scoring system of N to 3, where "N" = normal, and "3" = most severe. Next, identify the level of Headache in the same manner by identifying the respective level on the display screen. Continue with the remainder of the parameters. When prompted to perform the Cognitive Test, follow the on-screen instructions and identify the score.
Follow the instructions in performing the Positional Test, and identify the findings with the patient in the Supine posture, and then in the Upright posture. The program will store the results in the patient's "Journal" file. Follow the prompt instructions in making an observation of the patient's shunt system, and select the findings from the list on the display screen. Perform an assessment of Proximal Patency, if applicable, or as instructed by the treating physician. Follow the prompt instructions and repeat the same for the remainder of the parameters.
Test results are stored in a Journal file and later on PC disks. To obtain
results, place the
Below, are Seventeen (17) Interventions Available
through Advanced Testing:
- Lay Down (Rest)
- Lay Down (Trendelenburg)
- Exercise and Straining
- Assume Upright Posture
- Bend Over at Waist with Head Down
- Use Finger or Other Means to Stop/Reduce CSF Flow thru Distal Catheter
- Use of Elastic Wrap Around Abdomen
- Manipulation of Abdomen and Distal End of Shunt Catheter
- Lower External Body/Shunt Pressure: Trip to Mountains/Barometric Chamber
- Raise External Body/Shunt Pressure: Submerge under Water/Barometric Chamber
- Percutaneous
- Lift and Loosen Scalp Over
- Change Pillow and Pressure Over
- Diamox Prescription Intervention and/or Therapy
- Palliative Medicines and Interventions
- Biofeedback, Stress Reduction, Visualization Techniques
- New Tandem Monitoring with ShuntCheck Test, ICP Tap, Isotope Clearance, and other Shunt Flow Testing
Test parameters in the DiaCeph Test are well recognized in field study and
hydrocephalus treatment. Test sensitivity and specificity has been corroborated
in radiographs and surgical findings in a few trials by Stephen Dolle, its
inventor. His 1998 Clinical Trial was effective in identifying anti-siphon
functional obstructions, proximal and distal shunt obstruction, shunt
dependency, and helped in managing of daily complaints and quality of life.
Below, Shunt Malfunctions/Outcomes A - N are Matched
to Test Data:
A. Proximal Catheter/Valve Obstruction
B. Proximal Obstruction w/ Collapsed Vent.
C. Proximal Disconnect of Components
D. Infection w/ Proximal Valve Obstruction
E. NORMAL System Function
F. NORMAL Function w/ CSF Underdrainage
G. Shunt Overdrainage/Hypotension (incl. ASDs)
H. ASD Shunt Overfunction w/ Underdrainage
I. Distal Catheter/Valve Obstruction
J. Mal-Positioned Distal Catheter
K. Distal Disconnect of Components
L. Infection w/ Distal Obstruction
M. Other Pathology/Seizure Activity
N. Decompensated Hydrocephalus
Results
and Display:
DiaCeph results are available on the unit display, and on hard copy after downloading to PC. After downloading to PC, data is plotted as Time v. Parameter Values graphs as noted below:
1. Graph of shunt patency values with overlay to baseline
2. Graph of relative ICP values with overlay to baseline
3. Graph of individual parameters with overlay to baseline
4. Graph of cognitive values with overlay to baseline
5. Graph of interventional data with overlay to prior samplings
6. Display of most probable malfunction(s) from list of 14 possible
7. Display of relative ICP values for each monitoring point
8. Display of
shunt patency values of proximal, distal, and refill scoring
Processing
Algorithms:
1. Algorithm determines relative ICP from the following parameter values:
nausea score
headache score
malaise, eye signs, or balance score
cognitive score
positional test score
2. Algorithm determines shunt patency from the following parameter values:
nausea score
headache score
malaise, eye signs, or balance score
relative ICP score
percutaneous finger assessment of patency